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1 S FOR ISSUE ON IMPORT S.NO. NAME OF APPLICANT DIARY NO. TYPE OF 1. TABLETS (INDIA) LIMITED 5973 APPROVAL 2. TABLETS (INDIA) LIMITED 5974 APPROVAL 3. CLARIS OTSUKA PRIVATE LIMITED 7373 APPROVAL 4. VITAL HEALTHCARE PVT. LTD APPROVAL 5. KUSUM HEATLHCARE PVT. LTD APPROVAL 6. SAMARTH LIFE SCIENCES PVT. LTD APPROVAL (UNIT-II) 7. PFIZER PRODUCTS INDIA PVT. LTD APPROVAL 8. ASTRAZENECA PHARMA INDIA 5697 APPROVAL LIMITED 9. ADD-BIOTEC 7803 APPROVAL 10. TROIKAA PHARMACEUTICALS LTD., 7063 APPROVAL 11. TROIKAA PHARMACEUTICALS LTD., 7064 APPROVAL 12. GUTHY RENKER MARKETING PVT. LTD 7971 CLARIFICATION REGISTRATION S.NO. NAME OF APPLICANT DIARY NO. TYPE OF 1. NEXT GEN PHARMA INDIA PVT AMENDED LTD. 2. UCB INDIA PVT. LTD 3176 AMENDED 3. JOHNSON & JOHNSON PVT. LTD FDC DIVISION S.NO. NAME OF COMPANY DIARY NO DOCUMENT 1. M/S. GLAXOSMITHKLINE ASIA PVT. LTD., M/S. TORRENT PHARMACEUTICALS LTD., M/S. FAMY CARE LTD., M/S. FAMY CARE LTD., M/S. INDIA MEDTRONIC PVT. LTD., 408
2 6. M/S. INDIA MEDTRONIC PVT. LTD., M/S. LABINDUSS LTD., M/S. MERIDIAN ENTERPRISES PVT. LTD., M/S. AKUMS DRUGS & PHARMACEUTICALS LTD., M/S. INTAS PHARMACEUTICALS LTD., M/S. TAKEDA PHARMACEUTICALS INDIA M/S. SARDIA PHARMACEUTICALS INDIA M/S. NATCO PHARMA NIL SEC 14. M/S. PFIZER LTD., M/S. RPG LIFE SCIENCES M/S. VERIZON GENESIS NIL BIOLOGICAL DIVISION S. COMPANY NAME/ FILE NO DY. NO STATUS NO. 1 M/S DR. REDDY S 5229, 4397 APPROVAL LABORATORIES LTD 2 M/S ROCHE PRODUCTS 7375 APPROVAL INDIA PVT, LTD 3 M/S PFIZER LTD 7852, 2114 CLARIFICATION 4 M/S BHARAT BIOTECH INTERNATIONAL LTD 2160, APPROVAL & CLARIFICATION 5 M/S HLL LIFECARE LTD CLARIFICATION 6 M/S SANOFI SYNTHELABO 4201 CLARIFICATION INDIA PVT, LTD 7 M/S SANDOR MEDICAIDS 5443 CLARIFICATION PVT, LTD 8 M/S ALCON LABORATORIES 7116 CLARIFICATION INDIA PVT, LTD 9 M/S WOCKHARDT LTD 4114 CLARIFICATION 10 M/S M.J. BIOPHARM 706 CLARIFICATION PVT,LTD 11 M/S SYNGENE 7441 APPROVAL
3 INTERNATIONAL LTD 12 M/S CLIANTHA RESEARCH LTD 13 M/S ACCUTEST RESEARCH LABORATORIES I PVT, LTD 14 M/S MERCK SPECIALITIES PVT, LTD 15 M/S CHIRON BEHRING VACCINE PVT, LTD 7811 APPROVAL 7840, 7839 APPROVAL APPROVAL APPROVAL GLOBAL CLINICAL TRIAL SR. NO. COMPANY NAME REFERENCE STATUS 1 M/S. NOVO NORDISK - SEC MEETING 2 M/S. JSS 1259 CHANGE IN CRO, TL & EXPORT NOC APPROVAL S MEDICAL DEVICE S.NO. COMPANY NAME DIARY NO STATUS 1. M/S. BOSTON SCIENTIFIC INDIA PVT. LTD APPROVAL (E-IL) 2. M/S. BOSTON SCIENTIFIC INDIA PVT. LTD M/S. BOSTON SCIENTIFIC INDIA PVT. LTD QUERY 4. THE DRUGS CONTROLLER, BANGALORE (CLAA) THE DEPUTY DRUGS CONTROLLER, BANGALORE (CLAA) M/S. BLUE NEEM MEDICAL DEVICES PVT. LTD. 5. THE JOINT COMMISSIONER (K.D.), THANE (CLAA) THE DEPUTY DRUGS CONTROLLER, MUMBAI (CLAA) M/S. RCH ORTHOPAEDICS, THANE FTS. NO FTS. NO APPROVAL QUERY
4 SUBSEQUENT NEW DRUG S. NO. NAME OF THE FIRM REFERENCE NO. FTS NO. TYPE OF 1. M/S MARTIN AND HARRIS LABORATORIES LTD. - - COSMETIC DIVISION S. NO. COMPANY NAME DIARY NO. STATUS 1. M/S. EKATRA HOSPITALITY VENTURES PVT. LTD, NEW DELHI APPROVAL 2. M/S. LOTUS HERBALS PVT. LTD, UTTAR PRADESH 52116, 140, 5823 APPROVAL 3. M/S. FASHION IDENTITY PVT. LTD, MUMBAI 574 APPROVAL 4. M/S. PARAMOUNT COSMETICS (INDIA) LIMITED, BANGALORE 5. M/S. SISO IMPORTERS & TRADERS PVT. LTD, KERALA 6. M/S. SIT PVT. LTD, (SISO IMPORTERS & TRADERS PVT. LTD, KERALA 591 APPROVAL 1000 APPROVAL 1001 APPROVAL 7. M/S. VALEO NUTRA PVT. LTD, MUMBAI 2762 APPROVAL 8. M/S. ALPINE TRADERS LINKS, NEW DELHI 2966 APPROVAL 9. M/S. SHARAYA INTERNATIONAL, NEW DELHI 3232 APPROVAL
5 10. M/S. PERFECT WAY TRADING, MUMBAI 4127 DEFICIENCY 11. M/S. BAJORIA FOODS PVT LTD, MUMBAI 5980 APPROVAL 12. M/S. BAUSCH AND LOMB (INDIA) PVT. LTD, GURGAON 13. M/S. HENKEL ADHESIVES TECHNOLOGIES INDIA PVT LTD, CHENNAI 6097 APPROVAL 6319 APPROVAL 14. M/S. JONHSON & JOHNSON, MUMBAI 6972 APPROVAL GLOBAL CLINICAL TRIAL SR. NO. COMPANY NAME REFERENCE STATUS 1 M/S. MAYA CLINICALS 4392/4783/4784/1357 NEW SITE / PA APPROVAL S 2 M/S. CADILA 34672/238/50492 CHANGE IN PI/NEW SITE APPROVAL S 3 M/S. NOVO NORDISK 6694 TL APPROVAL BE NOC FOR EXPORT S. NO. NAME OF THE COMPANY REF. NO. TYPE OF 1. M/S. ACCUTEST RESEARCH 2. M/S. ACCUTEST RESEARCH 3. M/S. ACCUTEST RESEARCH 5825 APPROVAL 5824 APPROVAL 7448 APPROVAL
6 4. M/S. ACCUTEST RESEARCH 5. M/S. ACCUTEST RESEARCH 6. M/S. ACCUTEST RESEARCH 7. M/S. ACCUTEST RESEARCH 8. M/S. ACTIMUS BIOSCIENCES PVT. LTD., VISAKHAPATNAM , ANDHRA PRADESH 9. M/S. AJANTA PHARMA LIMITED, MUMBAI M/S. ALEMBIC PHARMACEUTICALS LTD., VADODARA M/S. ALEMBIC PHARMACEUTICALS LTD., VADODARA M/S. ALEMBIC PHARMACEUTICALS LTD., VADODARA M/S. ALKEM LABORATORIES LTD., TALOJA , TAL: PANVEL, DIST: RAIGAD 14. M/S. ALKEM LABORATORIES LTD., TALOJA , TAL: PANVEL, DIST: RAIGAD 15. M/S. ALKEM LABORATORIES LTD., TALOJA , TAL: PANVEL, DIST: RAIGAD 16. M/S. ANACIPHER CLINICAL RESEARCH ORGANISATION (A DIVISION OF INDOCO REMEDIES LTD.), HYDERABAD APPROVAL 6219 TEST LICENCE 7223 TEST LICENCE 5107 AMENDMENT 5636 CLARIFICATION 6322 CLARIFICATION 5721 APPROVAL 6233 APPROVAL 6406 APPROVAL 5953 AMENDMENT 5954 APPROVAL 6471 APPROVAL 6124 APPROVAL
7 17. M/S. ANACIPHER CLINICAL RESEARCH ORGANISATION (A DIVISION OF INDOCO REMEDIES LTD.), HYDERABAD M/S. APL RESEARCH CENTRE, AUROBINDO PHARMA LTD., HYDERABAD M/S. APL RESEARCH CENTRE, AUROBINDO PHARMA LTD., HYDERABAD M/S. APL RESEARCH CENTRE, AUROBINDO PHARMA LTD., HYDERABAD M/S. AXIS CLINICALS LTD., HYDERABAD M/S. AXIS CLINICALS LTD., HYDERABAD M/S. AZIDUS LABORATORIES LTD., CHENNAI M/S. CADILA HEALTHCARE LTD., AHMEDABAD M/S. CIPLA LIMITED, MUMBAI M/S. CIPLA LIMITED, MUMBAI M/S. CIPLA LIMITED, MUMBAI M/S. CLIANTHA RESEARCH LIMITED, AHMEDABAD M/S. CLIANTHA RESEARCH LIMITED, AHMEDABAD M/S. CLIANTHA RESEARCH LIMITED, 31. M/S. CLIANTHA RESEARCH LIMITED, 1747 APPROVAL 6185 APPROVAL 6968 APPROVAL 6452 TEST LICENCE 6570 CLARIFICATION 6571 CLARIFICATION 5546 CLARIFICATION 6131 CLARIFICATION 5828 APPROVAL 990 APPROVAL 6049 AMENDMENT TEST LICENCE TEST LICENCE 134 ADDITIONAL STUDY CENTER 5959 ADDITIONAL STUDY CENTER
8 32. M/S. CLIANTHA RESEARCH LIMITED, 33. M/S. CLIANTHA RESEARCH LIMITED, 34. M/S. CLIANTHA RESEARCH LIMITED, 35. M/S. CLIANTHA RESEARCH LIMITED, 36. M/S. CLIANTHA RESEARCH LIMITED, 37. M/S. CLIANTHA RESEARCH LIMITED, 38. M/S. CLIANTHA RESEARCH LIMITED, 39. M/S. CLIANTHA RESEARCH LIMITED, 40. M/S. CLIANTHA RESEARCH LIMITED, 41. M/S. CLIANTHA RESEARCH LIMITED, 42. M/S. CLIANTHA RESEARCH LIMITED, 43. M/S. DR. REDDY S LABORATORIES LTD., HYDERABAD M/S. DR. REDDY S LABORATORIES LTD., HYDERABAD M/S. DR. REDDY S LABORATORIES LTD., HYDERABAD M/S. HETERO LABS LTD., HYDERABAD M/S. HETERO LABS LTD., HYDERABAD M/S. HETERO LABS LTD., HYDERABAD APPROVAL 6024 APPROVAL 6025 APPROVAL APPROVAL 6135 APPROVAL APPROVAL 6134 APPROVAL 6334 APPROVAL 6332 APPROVAL 6333 APPROVAL 6338 APPROVAL 6442 CLARIFICATION 5819 APPROVAL 6501 APPROVAL 6460 APPROVAL 6459 APPROVAL 6793 APPROVAL
9 49. M/S. JUBILANT GENERICS LTD., NOIDA , UP 50. M/S. JUBILANT GENERICS LTD., NOIDA , UP 51. M/S. KUSUM HEALTHCARE PVT. LTD., NEW DELHI M/S. LAMBDA THERAPEUTIC RESEARCH LTD., AHMEDABAD M/S. LAMBDA THERAPEUTIC RESEARCH LTD., NAVI MUMBAI M/S. LOTUS LABS PVT. LTD., BANGALORE M/S. LOTUS LABS PVT. LTD., BANGALORE M/S. LOTUS LABS PVT. LTD., BANGALORE M/S. LOTUS LABS PVT. LTD., BANGALORE M/S. LOTUS LABS PVT. LTD., CHENNAI M/S. LOTUS LABS PVT. LTD., CHENNAI M/S. LUPIN LIMITED (RESEARCH PARK), PUNE M/S. MACLEODS PHARMACEUTICALS LTD., ANDHERI (EAST), MUMBAI M/S. MANIPAL ACUNOVA LIMITED, MANGALORE M/S. MANIPAL ACUNOVA LIMITED, MANIPAL M/S. MANIPAL ACUNOVA LTD., MANGALORE APPROVAL 6232 APPROVAL 5904 TEST LICENCE 687 APPROVAL 6307 APPROVAL 5793 APPROVAL 6107 APPROVAL 6105 CLARIFICATION 6106 APPROVAL 5077 APPROVAL 6548 APPROVAL 6213 APPROVAL 5950 APPROVAL 5909 CLARIFICATION 6448 APPROVAL 6449 APPROVAL
10 65. M/S. MANIPAL ACUNOVA LTD., MANGALORE M/S. MICRO THERAPEUTIC RESEARCH LABS PVT. LTD., CHENNAI M/S. MICRO THERAPEUTIC RESEARCH LABS PVT. LTD., CHENNAI M/S. NORWICH CLINICAL SERVICES PVT. LTD., BANGALORE M/S. PANEXCELL CLINICAL LAB PVT. LTD., NAVI MUMBAI M/S. PANEXCELL CLINICAL LAB PVT. LTD., NAVI MUMBAI M/S. PAR BIOSCIENCES PRIVATE LIMITED, CHENNAI M/S. PAR BIOSCIENCES PRIVATE LIMITED, CHENNAI M/S. PAR BIOSCIENCES PRIVATE LIMITED, CHENNAI M/S. PAR BIOSCIENCES PRIVATE LIMITED, CHENNAI M/S. QPS BIOSERVE INDIA PVT. LTD., HYDERABAD M/S. RA CHEM PHARMA LTD., BALANAGAR, HYDERABAD M/S. RAPTIM RESEARCH LTD., NAVI MUMBAI M/S. RAPTIM RESEARCH LTD., NAVI MUMBAI M/S. RELIANCE LIFE SCIENCES PVT. LTD., NAVI MUMBAI M/S. SANCILLIO PHARMACEUTICALS PVT. LTD., THANE (WEST) APPROVAL REJECTION 6054 APPROVAL 5792 AMENDMENT 6024 APPROVAL 6880 APPROVAL 5731 CLARIFICATION 5730 CLARIFICATION 5049 APPROVAL 5853 APPROVAL 6480 APPROVAL 5381 CLARIFICATION 5577 APPROVAL 5920 APPROVAL 4300 TEST LICENCE 5054 CLARIFICATION
11 81. M/S. SIDMAK LABORATORIES (INDIA) PVT. LTD., ABRAMA, VALSAD M/S. STRIDES SHASUN LTD., BANGALORE M/S. SUN PHARMACEUTICAL INDUSTRIES LTD., HARYANA 84. M/S. SUN PHARMACEUTICAL INDUSTRIES LTD., VADODARA M/S. SUN PHARMACEUTICAL INDUSTRIES LTD., VADODARA M/S. SUN PHARMACEUTICAL INDUSTRIES LTD., VADODARA M/S. SUN PHARMACEUTICAL INDUSTRIES LTD., VADODARA M/S. SUN PHARMACEUTICAL INDUSTRIES LTD., VADODARA M/S. SUN PHARMACEUTICAL INDUSTRIES LTD., VADODARA M/S. SYNAPSE LABS PVT. LTD., KHARADI, PUNE M/S. SYNAPSE LABS PVT. LTD., KHARADI, PUNE M/S. SYNGENE INTERNATIONAL LTD., BANGALORE M/S. VEEDA CLINICAL RESEARCH PVT. LTD., AHMEDABAD M/S. VEEDA CLINICAL RESEARCH PVT. LTD., AHMEDABAD APPROVAL 7016 AMENDMENT 6209 APPROVAL 5899 AMENDMENT 6210 CLARIFICATION 3305 CLARIFICATION APPROVAL 6272 APPROVAL 6271 APPROVAL 6584 APPROVAL 6583 APPROVAL 6035 APPROVAL 1386 APPROVAL 5985 TEST LICENCE 95. M/S. VEEDA CLINICAL RESEARCH 5987 CLARIFICATION
12 PVT. LTD., AHMEDABAD M/S. VEEDA CLINICAL RESEARCH PVT. LTD., AHMEDABAD M/S. VEEDA CLINICAL RESEARCH PVT. LTD., AHMEDABAD M/S. VEEDA CLINICAL RESEARCH PVT. LTD., AHMEDABAD M/S. VEEDA CLINICAL RESEARCH PVT. LTD., AHMEDABAD M/S. VEEDA CLINICAL RESEARCH PVT. LTD., AHMEDABAD M/S. VERGO CLINICALS, GOA M/S. VIMTA LABS LTD., HYDERABAD M/S. WATSON PHARMA PVT. LTD., NAVI MUMBAI M/S. WATSON PHARMA PVT. LTD., NAVI MUMBAI M/S. WATSON PHARMA PVT. LTD., NAVI MUMBAI M/S. WATSON PHARMA PVT. LTD., NAVI MUMBAI APPROVAL 5986 APPROVAL 5984 APPROVAL 6541 APPROVAL 6294 APPROVAL 6412 CLARIFICATION 5557 APPROVAL ADDITIONAL STUDY CENTER 6116 CLARIFICATION 6103 APPROVAL 6104 APPROVAL
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